Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
for Curatoderm Ointment contains tacalcitol which is a drug that belongs to a group of medicines called antipsoriatics and is a vitamin D derivative. Curatoderm Ointment is used to treat a condition known as psoriasis vulgaris. Psoriasis is a skin disorder in which itchy, red, flaky patches appear on the skin or scalp. Within affected areas of skin, new cells are being produced faster than normal, but old dead cells are only being shed at the normal rate. As live skin cells accumulate, the skin becomes thickened and inflamed. Curatoderm Ointment works by slowing down cell production and bringing it back to normal and helps reduce inflammation.
e Curatoderm Ointment Do not use Curatoderm Ointment
if you are allergic to tacalcitol or any of the other ingredients of this medicine (listed in section 6). if you have ever had problems with too much calcium in your blood (hypercalcaemia or other disorders of calcium metabolism). If this applies to you do not use this medicine and speak to your doctor.
Take special care with Curatoderm Ointment When applying Curatoderm Ointment to the face: Do not allow the Ointment to come in contact with the eyes. If it does, rinse thoroughly with water. Warnings and precautions Talk to your doctor before using Curatoderm Ointment if
you have or have had problems with your kidneys, you have a particular type of psoriasis called generalized pustular psoriasis or erythrodermic exfoliative psoriasis, you are taking high doses of vitamin D (more than 500IU)
Your doctor may want to check the level of calcium in your blood if you have any of these conditions. Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Children and adolescents The safety and efficacy of Curatoderm Ointment in children and adolescents under 18 years have not been established. Other medicines and Curatoderm Ointment Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially: Multivitamin products or vitamin D If you are receiving ultraviolet (UV) therapy, this should be given in the morning and Curatoderm Ointment used at bedtime. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. The potential risk to the baby if Curatoderm Ointment is used during pregnancy is unknown. Therefore if you are pregnant or likely to become pregnant whilst using Curatoderm Ointment make sure your doctor knows. It is not known if Curatoderm Ointment passes into breast milk. Only a small amount is absorbed into the body after skin treatment. It is probably not necessary to stop breast-feeding during treatment. If the breast area is affected by psoriasis, it is recommended that the breast area is not treated with Curatoderm Ointment or breast-feeding should be stopped. Discuss this with your doctor. Driving and using machines
Curatoderm Ointment is not expected to have any effect on your ability to drive or use machines. Curatoderm contains butylhydroxytoluene (E 321) contained in the excipient Paraffin, white soft. Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Curatoderm Ointment Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use in children Curatoderm Ointment is not recommended for use in children, as there is limited experience. Curatoderm Ointment is for use by adults including the elderly. Curatoderm Ointment can be used on all areas of the body including face, hairline, scalp, armpits, elbows and knees. Follow your doctor's instructions for use exactly. The following are general guidelines:
Apply Curatoderm Ointment once a day, preferably at bedtime. Don't use more than 10 grams of ointment (about the size of a chestnut) each day. Spread the ointment thinly over the areas of skin affected by psoriasis. If you are using the ointment on your scalp it can be shampooed out the next morning. Avoid transfer of the ointment to other areas of your body not affected by psoriasis. Wash your hands as soon as you have finished using the ointment.
Duration of treatment
Your doctor will tell you for how long you need to use the ointment.
If you also use Curatoderm Lotion
Curatoderm is also available as a lotion. If you are using Curatoderm Lotion, take into the account that the quantity of applied tacalcitol adds up. You should not use more than 280 micrograms of tacalcitol per week. That is for example equivalent to 40g Curatoderm Ointment plus 30ml Curatoderm Lotion per week.
If you use more Curatoderm Ointment than you should It is important to tell your doctor if you have used too much Curatoderm Ointment, as it may be necessary to check the amount of calcium in your blood. If you forget to use Curatoderm Ointment If you forget to use Curatoderm Ointment at the usual time, use it as soon as you remember, then carry on as before. Do not apply two doses at the same time. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local skin reactions such as itching, burning or redness may be experienced. Sometimes the ointment makes your skin redder and more irritated for a short time after you have applied it. On rare occasions, mild contact dermatitis or a worsening of the skin condition may occur.
These are usually mild effects and don't last very long. The following side effects have also been reported (frequency not known, cannot be estimated from the available data): Elevated calcium levels in the blood (hypercalcaemia). Hypersensitivity reactions (including swelling, oedema and face oedema). Rash (erythematous, macular, papular, vesicular). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Curatoderm Ointment Keep this medicine out of the sight and reach of children. Curatoderm Ointment should be stored below 30°C. Do not use this medicine after the expiry date which is stated on the label after "EXP:". The expiry date refers to the last day of that month. Do not use for longer than 6 months after first opening the tube. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Curatoderm Ointment contains The active substance is tacalcitol There are 4 micrograms of tacalcitol (the active ingredient) in each gram of ointment The other ingredients are paraffin, white soft (contains butylhydroxytoluene E321), liquid paraffin and diisopropyl adipate. What Curatoderm Ointment looks like and contents of the pack
Curatoderm Ointment is a translucent and white, glossy ointment. Your medicinal product comes in either 5g, 20g, 30g or 100g aluminium tubes with a screw cap. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Almirall Hermal GmbH Scholtzstraße 3, 21465 Reinbek, Germany. tel: +49 +40 727 04-0 fax: +49 +40 722 92 96 [email protected] www.almirall.com This leaflet was last revised in: 05/2020
Curatoderm 4μg/g Ointment comes as ointment containing 4μg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Curatoderm 4μg/g Ointment is tacalcitol monohydrate.
This leaflet reproduces the patient information leaflet approved for Curatoderm 4μg/g Ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Curatoderm ointment is indicated for the treatment of psoriasis vulgaris in adults.
Posology
Adults and the Elderly:
Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed l0g of ointment/day. Ointment). Normally duration of treatment depends on the severity of the lesions and should be decided by the physician. There is clinical trial experience with continuous and intermittent treatment in adults up to twelve months.
Curatoderm Ointment can be used on all areas of the body (including face, hairline, scalp, axilla and other flexures).
When used on the scalp the ointment can be shampooed out the next morning.
Paediatric population:
The safety and efficacy of Curatoderm Ointment in children and adolescents under 18 years have not been established.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Patients with hypercalcaemia or other known disorders of calcium metabolism.
At the doctor's discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely monitored. Treatment should be stopped if hypercalcaemia occurs.
Serum calcium levels should also be monitored in patients with renal impairment. Care should be exercised in patients with generalised pustular or erthrodermic psoriasis as the risk of hypercalcaemia may be enhanced.
When applying to the face avoid contact with the eyes. Patients should be advised to wash their hands after applying the ointment to avoid inadvertent transfer to other parts of the body.
Butylhydroxytoluene (E 321) contained in the excipient Paraffin, white soft, may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D.
UVB radiation can be combined with Curatoderm Ointment. This approach increases the efficacy of the treatment and shortens the radiation period. UV radiation should be given in the morning and Curatoderm Ointment at bedtime. There has been limited experience of the concomitant use of Curatoderm Ointment with topical corticosteroids, urea, emollients, dithranol cream and PUVA.
Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation or peri- or postnatal development. Avoid use in pregnancy unless there are no safer alternatives.
Lactation
During lactation the breast area should not be treated. It is not known whether tacalcitol is excreted in human breast milk.
Not relevant.
The data given for frequency of adverse reactions is based on the following categories:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to 1/1,000)
Very rare (< 1/10,000)
Not known (frequency cannot be estimated from the available data)
Metabolism and nutrition disorders
Frequency unknown: Hypercalcaemia
Immune system disorders
Frequency unknown: Hypersensitivity reactions (including swelling, oedema and face oedema)
Skin and subcutaneous tissue disorders:
Rare: Skin irritation (e.g. burning, erythema), itching, contact dermatitis, worsening of psoriasis.
Skin irritation and itching are generally mild and transient
Frequency unknown: rash (erythematous, macular, papular, vesicular).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.
Overdosing by ingestion of an ointment is very unlikely. It cannot be excluded that topical application of excessive amounts may lead to hypercalcaemia. In this case Curatoderm treatment and other possible vitamin D or calcium supplement intakes must be stopped until serum calcium returns to normal.
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Curatoderm 4μg/g Ointment. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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